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REPtJRT 

SAtViTrzEo 

STATBfUlENT UN THE PYRQPHORiC PRAPBR1°IB S Of: 

1,1,3,3-TBI'RAiViBTHYLBUTYLPBROXY F'iVALA7"B 

~ _...;., 

NOTOX project, 

NOTOX Substanc~ 

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1,1,3,3-TETRAMETHYLSUTYLREROXY PIVALATE NOTOX Projec ` y, 

: 

CONF3QENTIALITY STATEMENT 

This report contains fhe unpublished results of research sponsored by Akzo Nobel Chem' icafs 

B.V.. Fteproduction, issue or disctosure to third Qarties in any form is not permitted without prior 

written authorfzation from the sponsor. 

~ r.J. ~ ~~~[ •~ ~~~~~~ i 

.2r 
Study Director 

Date~. 

1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Proje~ ~ 

STATEMENT OF GLP COMPLIANCE 

NOTOX B.V.,'s-Hertogenbosch, The Netherlands 

The study described in this report has been correotly reported and was conducted in compliance 

with the most recent edition of: 

The OECD Principles of Good Laboratory Practice 

which are essentialiy tn conformity with: 

The United States Food and Drug Administration. Title 21 Code of Federal Regulations Part 58. 

The United States EnvPronmental Protection Agency (FfFRA). Title 40 Code of Federal 

Regulations Part 160. 

The United States Environmental Protection Agency ('i'SCA). Titie 40 Code of Federal 

Regulations Part 792. . 

Management 

Dr. Ir. H. Wiliems 

~lHead-of_Chemistry 

Dafe: 

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1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Projec i \ ~ 

QUALITY ASSURANCE STATEMENT 

NOTOX B.V.,'s-Hertogenbosch, The Netherlands 

This report was audited by the NOTOX Quality Assurance Unit to ensure that the methods and 

results accurately reflect the raw data. 

The dates of Quality Assurance inspections and audits are given below. 

DATES OF QAU INSPECTIONS/AUDITS 

protocol inspection (s) 

11 February 1999 

report audit (s) 

16 August 1999 

Head of Quality Assurance 

C.J. Mitchell B.Sc. 

Date:~ 

REPORTING DATES 

11 February 1999 

16 August 1999 

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1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Pro'ect 

..~_.._. ~ ~ 

Sponsor AKZO Nobel Chemicals B.V. 

P.O. Box 247 

3800 AE Amersfoort 

Iholetherla. d 

Study Monitor ~f 

Testing Facility 

----- ---- ✓ NOTOX B.V.' 

Hambakenwetering 3 

5231 DD's-Hertogenbosch 

Th etherlands 

Study Director 

Study Plan Start : 13 August 1999 

Completed : 13 August 1999 

TESTSUBSTANCE 

Identification 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE 

AKZO Nobel trade name Trigonox 425 

Chemical name 1,1,3,3-Tetramethylbutylperoxy pivalate 

CAS no. 22288-41-1 

Description ---Colourtess-liqu'Ld 

Batch Number 

Purity ~'"~--See-Certificate of-Ana(ysis 

Test substance storage In freezer in the dark 

Stability under storage 

conditions Stable 

Expiry date 01 January 2000 

The sponsor is responsible for the completeness and GLP Compiiance of all 

testsubstance data. 

The purpose of the study was to evaluate the pyrophoric properties of the test substance. 

GUIDELINES 

The procedures for the determination of the pyrophoric properties are described tn the following 

guidefine: 

European Economic Community (EEC), EEC directive 92/69 EEC, Part A, Methods for the 

determination of physioo-chemical properties, A-13: "Pyrophoric properties of solids and 

liquids", EEC Publicatfon No. L383, December 1992. 

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1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Proj ct 

ARCH IVING 

NOTOX B.V. wilf archive the following data for at least 10 years: 

protocol, report, test substance reference sample and raw data. Thereafter, no data will be 

withdrawn wifhout the sponsor's written consent. 

From the composition and the structuraf formula of 1,1,3,3-TETRAMETHYLBUTYLPEROXY 

PIVALATE (see Appendix and Figure 1, respectively), it can be concluded that 1,1,3,3- 

TETRAMETHYLBUTYLPEROXY PIVALATE is not pyrophoric. The test substance does not 

contain any chemical group that might lead to spontaneous ignition a short time after coming 

into contact with air at room temperature (circa 20 0C). 

Furthermore, experience in handling shows that the test substance does not ignite coming in 

contact with air. 

O 

~O/O 

Figure 1. Structural formula of 1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE. 

M 
NOTOXProjectl ~ 

~~ 

1,1,3,3-TETRAMETNYLBUTYLPEROXY PIVALATE 

APPENDIX: CERTIFICATE OFANALYSIS 

AKZO iV±DBEL ® 

Product name : 1,1,3,3-tetramethylbutyl 

Tradename : Trigonox425 

Batch numbe r t 

Centra! Research 

page 1 of 2 

File code 

Analytical documentation ~ 

Authodzed by''—° '-, -- -- 

Name 

Function 

Date 

Signature 

~ 

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1,1,3,3-TETRAMETHYLBUTYLPEROXY PIVALATE NOTOX Projeot 

t/ 

14KZ0 NOBEL o• i ~ o 

Centrcrl Research 

page 2 or2 

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